Recall Z-0753-2024— Randox Laboratories Ltd.
Class II · Ongoing
Class II FDA medical device recall by Randox Laboratories Ltd., initiated 2023-11-20. It names one FDA 510(k) clearance: K053153. Product: Calibration Serum Level 3 - IVD For use as a Calibrator in clinical chemistry assays Catalog Number: CAL2351. Reason: Target for Alkaline Phosphatase (ALP) for the AMP optimized to IFCC 37¿C method has been mis-assigned for the RX Series instruments by approximately 10% on Quality Control and patient samples.
- Recalling firm
- Randox Laboratories Ltd.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-11-20
- Firm location
- Crumlin (North), N/A, Ireland
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Calibration Serum Level 3 - IVD For use as a Calibrator in clinical chemistry assays Catalog Number: CAL2351
Reason for recall
Target for Alkaline Phosphatase (ALP) for the AMP optimized to IFCC 37¿C method has been mis-assigned for the RX Series instruments by approximately 10% on Quality Control and patient samples
Data sourced from openFDA. This site is unofficial and independent of the FDA.